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Background: The safety of subcutaneous implantable cardioverter defibrillator (S-ICD) recipients who lead active lifestyles and engage in recreational sports is unknown. We aimed to evaluate the association between lifestyle and recreational sports and the occurrence of arrhythmia- and device-related complications, appropriate and inappropriate shocks in S-ICD recipients., Methods: We assessed a cohort of young-adult (15-65 years) S-ICD patients, evaluated their physical activity with IPAQ (International Physical Activity Questionnaire), and assessed the association between lifestyle and recreational sports on S-ICD safety and shocks., Results: We enrolled 602 S-ICD recipients (77% males; age, 46±14 years). According to the IPAQ, patients were categorized as inactive subjects (26.4%), moderately active subjects (45.2%), or highly active subjects (28.4%). Among moderately/highly active subjects, 163 (27.1%) were recreational athletes. During follow-up (47.3 [interquartile range, 27.0-67.6] months), 23 patients (3.8%) reached the safety end point of arrhythmia- or device-related complications, with moderately and highly active subjects showing in multivariate analysis similar incidence compared with inactive subjects ( P =0.59 and P =0.83, respectively). Forty-four patients had 87 appropriate shocks. In multivariate analysis, moderately and highly active subjects showed a nonsignificantly lower incidence of appropriate shocks compared with inactive subjects ( P =0.12 and P =0.11, respectively). Consistently, there was a nonsignificant lower incidence of appropriate shocks in athletes versus nonathletes ( P =0.06). Thirty-nine patients had 46 inappropriate shocks. Moderately and highly active subjects had similar incidence of inappropriate shocks compared with inactive subjects ( P =0.92 and P =0.88, respectively)., Conclusions: Young S-ICD patients often lead active lifestyles and participate in sports. Higher activity levels were not associated with increased implantable cardioverter defibrillator-related complications or increased risk of implantable cardioverter defibrillator shocks.

Objective: The EXPAND registry is a post-market, multicenter registry that aims at evaluating the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. This subgroup analysis assesses the 3-year outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair., Methods: This prospective, multicenter, observational registry includes 16 European sites. Patients were enrolled from November 2018 to March 2022. Endpoints included 3-year primary patency (PP), secondary patency (SP), and stent graft-related death and serious adverse events., Results: Seventy-three patients, of whom 57 (78.1%) were male, with a mean age of 73 years (±8.1 years) were included. At 3 years, 42 patients (57.5%) returned for follow-up. Overall, 223 target vessels (TVs) were treated. The estimated freedom from loss of TV PP was 93.6%. Per TV PP rates were 97.0% for the celiac trunk, 93.9% for the superior mesenteric artery, 91.2% for the left renal artery, and 92.5% for the right renal artery. The overall estimated freedom from loss of SP was 96.8%, and freedom from TV instability was 94.5%., Conclusions: The VBX stent demonstrated excellent sustained results at 3 years with almost 94% PP, 97% SP, and 94.5% freedom from TV instability. Patency in the renal arteries was lower than in the celiac trunk and superior mesenteric artery. The VBX stent appears to be a reliable bridging stent for target vessels in branched endovascular aortic repair., Competing Interests: Disclosures M.G., S.H., I.T., D.B., H.V., A.M.F., M.J.A. are Clinical Investigators for Gore Medical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Aims: To investigate the impact of an early coronary revascularization (<24 h) compared with initial conservative strategy on clinical outcomes in diabetic patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) who are in stable condition at hospital admission., Methods and Results: The International Survey of Acute Coronary Syndromes database was queried for a sample of diabetic and nondiabetic patients with diagnosis of NSTE-ACS. Patients with cardiac arrest, haemodynamic instability, and serious ventricular arrhythmias were excluded. The characteristics between groups were adjusted using logistic regression and inverse probability of treatment weighting models. Primary outcome measure was all-cause 30-day mortality. Risk ratios (RRs) and odds ratios (ORs) with their 95% confidence intervals (CIs) were employed. Of the 7589 NSTE-ACS patients identified, 2343 were diabetics. The data show a notable reduction in mortality for the elderly (>65 years) undergoing early revascularization compared to those receiving an initial conservative strategy both in the diabetic (3.3% vs. 6.7%; RR: 0.48; 95% CI: 0.28-0.80) and nondiabetic patients (2.7% vs. 4.7%: RR: 0.57; 95% CI: 0.36-0.90). In multivariate analyses, diabetes was a strong independent predictor of mortality in the elderly (OR: 1.43; 95% CI: 1.03-1.99), but not in the younger patients (OR: 1.04; 95% CI: 0.53-2.06)., Conclusion: Early coronary revascularization does not lead to any survival advantage within 30 days from admission in young NSTE-ACS patients who present to hospital in stable conditions with and without diabetes. An early invasive management strategy may be best reserved for the elderly. Factors beyond revascularization are of considerable importance for outcome in elderly diabetic subjects with NSTE-ACS., Clinical Trial Number: ClinicalTrials.gov: NCT01218776., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Diagnosing cardiac sarcoidosis (CS) is challenging. Immunosuppressive therapies are less effective in end-stage disease, and often heart transplant (HT) is the only available option. We present a series of advanced CS cases, requiring HT, along with a review of the literature evidence in this field., Case Summary: Case 1: a 49-year-old man initially suspected of having arrhythmogenic cardiomyopathy (ACM) presented with heart failure (HF) and recurrent ventricular arrhythmias. The rapid clinical deterioration raised suspicion of an inflammatory aetiology, which was confirmed through endomyocardial biopsy, diagnosing CS. Despite immunosuppressive therapy, HT was required. Case 2: a 36-year-old woman presented with high-grade atrioventricular block and dilated cardiomyopathy (DCM), initially diagnosed as idiopathic. Due to worsening HF, she required HT. The pathological examination of the explanted heart revealed CS. Chronic subclinical antibody-mediated rejection was observed after HT. Case 3: a 44-year-old man presented with syncope and imaging suggesting ACM. He was referred for HT due to high ventricular arrhythmic burden. Cardiac sarcoidosis diagnosis was suspected due to pulmonary involvement and then confirmed on post-explant pathological exam. Post-HT pulmonary and cutaneous sarcoidosis reactivation were observed. Case 4: a 43-year-old man was diagnosed with pulmonary sarcoidosis after lung biopsy. Progression towards DCM was observed despite immunosuppressive therapy. Post-HT was characterized by multiple episodes of graft rejection., Discussion: This case series provides insights into mid- and long-term outcomes after HT for CS, highlighting the need for careful management of immunosuppression in these patients, balancing the adverse effects of chronic immunosuppression with the prevention of rejection and sarcoidosis recurrence., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objective: Comprehensive endovascular aortic programmes need optimal infrastructure and multidisciplinary teams to manage complex aortic aneurysms. This study assessed the implementation of such a programme in two centres and its impact on fenestrated or branched endovascular aortic repair (FB-EVAR) outcomes., Methods: A retrospective review of patients treated for complex abdominal and thoraco-abdominal aortic aneurysms (TAAAs) by FB-EVAR between 2013 and 2023 was undertaken. All FB-EVAR patients were analysed, including investigational trials and high risk patients with physician modified endografts. Centre 1 (2013 - 2020) and Centre 2 (2020 - 2023) were compared. Primary endpoints were 30 day and or in hospital mortality and major adverse event (MAE) rates. Secondary endpoints were procedural metrics, spinal cord injuries, freedom from all cause death, failure to rescue, and one year mortality and re-intervention rates., Results: A total of 629 patients were included (475, 75.5% at Centre 1 and 154, 24.5% at Centre 2). The median age was 74 years (interquartile range 68, 79) and 441 (70.1%) were male. Centre 2 had a higher proportion of American Society of Anesthesiology class ≥ 3, genetically triggered aortic diseases (p = .002), chronic post-dissection aneurysms, prior aortic repairs, TAAAs (each p < .001), and symptomatic, larger aneurysms (p < .021). Technical success rates were similar between centres (97.9% vs. 98.1%; p = .91). The early mortality rate was 1.1% (7/629) with no statistically significant difference. No statistically significant differences (p > .050) in new onset permanent dialysis (0.6% vs. 2.0%), major stroke (0.6% vs. 0.6%), and permanent paraplegia (0.8% vs. 2.0%) were observed. Failure to rescue rates were 5.3% in Centre 2 and 3.5% in Centre 1 (p = .74). The one year mortality rate (91% vs. 89%; p = .71) and re-intervention rate (sub-distribution hazard ratio 1.30; p = .21) were similar between centres., Conclusion: FB-EVAR was performed with low mortality and risk of disabling complication rates. No differences in mortality and MAE rates were observed after establishing a comprehensive endovascular programme, despite higher risk and more extensive cases at the new institution., (Copyright © 2024. Published by Elsevier B.V.)

Background: Pediatric dermatology represents one of the most underserved subspecialties in pediatrics. Artificial intelligence (AI) and telemedicine have become considerable in dermatology, reaching diagnostic accuracy comparable to or exceeding that of in-person visits. This work aims to review the current state of telemedicine and AI in pediatric dermatology, suggesting potential ways to address existing issues and challenges., Methods: We conducted a literature review including only articles published in the last 15 years. A total of 458 studies were identified, of which only 76 were included., Results: Most of the studies on telemedicine evaluate accuracy focused on concordance, which ranges from 70% to 89% for the most common pediatric skin diseases. Telemedicine showed the potential to manage chronic dermatological conditions in children, as well as decrease waiting times, and represents the chance for unprivileged populations to overcome barriers limiting access to medical care. The main limitations of telemedicine consist of the language barrier and the need for adequate technologies and acceptable image-quality video, which can be overcome by AI. AI-driven apps and platforms can facilitate remote consultations between pediatric dermatologists and patients or their caregivers. However, the integration of AI into clinical practice faces some challenges ranging from technical to ethical and regulatory. It is crucial to ensure that the development, deployment, and utilization of AI systems conform to the seven fundamental requirements for trustworthy AI., Conclusion: This study supplies a detailed discussion of open challenges with a particular focus on equity and ethical considerations and defining possible concrete directions.

Background: Tunnels of hidradenitis suppurativa (HS) are one of the most challenging aspects to manage, and different surgical techniques have been proposed for their treatment. CO2 laser and surgical deroofing are 2 of the most widely used techniques, but no studies have compared them directly., Objective: The objective of this study was to compare the efficacy and outcomes of CO2 laser treatment versus surgical deroofing for HS tunnels, with a focus on healing time, complication rates, pain perception, and cosmetic outcomes., Materials and Methods: The authors performed a multicentric retrospective analysis of 20 patients with HS tunnels who were treated with either CO2 laser (n = 10) or surgical deroofing (n = 10). The primary end point was to compare the 2 procedures in terms of healing time, complication rates, pain, and cosmetic outcome. Outcome measures included Visual Analog Scale for pain, the Vancouver Scar Scale for scar evaluation, and the relapse rate at 6 months. Secondary end point included the identification of variables associated with the healing time., Results: The mean time to healing was 4.7 ± 1.9 weeks in the CO2 laser group and 10.9 ± 4.1 weeks in the surgical deroofing group (p < .01). Pain score at the first dressing change was lower in the CO2 laser group, with a mean Visual Analog Scale score of 1.7 ± 0.8 in the CO2 laser group and 4.9 ± 1.7 in the surgical deroofing group (p < .01). The mean scar evaluation score using the Vancouver Scar Scale at 6-month follow-up was 2.5 ± 1.3 in the CO2 laser group and 3.4 ± 1.1 in the surgical deroofing group. The number of postprocedural complications was low in both groups (1 in the CO2 laser group and 3 in the surgical deroofing group). The proportion of patients achieving complete healing of the tunnels at 6 months was similar among the CO2 laser and the surgical deroofing group (90% in the CO2 laser group vs 80% in the surgical group)., Conclusion: CO2 laser is a safe and effective treatment for HS tunnels, with fast healing rates and low pain perception., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.)

Perivascular epithelioid cell neoplasms (PEComas) and epithelioid angiomyolipomas (EAMLs) are two different denominations for the same "mesenchymal tumor composed of histologically and immunohistochemically distinctive perivascular epithelioid cells". Hepatic PEComa/EAML is a very rare neoplasm, and only 29 case reports of hepatic PEComa and 25 of hepatic EAML have been reported in the current literature. A clear female predominance with a mean age at diagnosis of 42.5 years old can be observed by literature review. Ultrasound (US) examination was the first-line diagnostic technique in most of the cases of hepatic PEComa, but it was documented in very few cases of hepatic EAML. A great variability in the ultrasonographic B-mode, color Doppler and contrast-enhanced ultrasonography (CEUS) features of hepatic PEComa/EAML emerges. Computed tomography and magnetic resonance were the most common used techniques to confirm the nature of the hepatic lesion, even if the anatomo-pathological examination was the only technique to display a certainty diagnosis and to differentiate hepatic PEComa/EAML from benign and malignant hepatic lesions. The great majority of hepatic PEComas/EAMLs are surgically treated without any adjuvant therapy., Competing Interests: Declarations Conflict of interest The authors declare they have no conflict of interest., (© 2024. Società Italiana di Ultrasonologia in Medicina e Biologia (SIUMB).)

The historical restriction of magnetic resonance imaging (MRI) for patients with cardiac implantable electronic devices (CIEDs) has been lifted by certified MRI-conditional systems in recent years. Mixed-brand CIED systems consisting of a generator from one manufacturer and at least one lead from another manufacturer are not certified for MRI. We evaluated the temporal trend in the prevalence of mixed-brand systems in the era of MRI-conditional systems. Data were analyzed on 5853 CIEDs implanted de novo between 2012 and 2022 in 81 Italian centers linked to the nationwide Home Monitoring Expert Alliance network. The percentage of mixed-brand implants was calculated by device type (pacemaker, implantable cardioverter-defibrillator [ICD], cardiac resynchronization therapy [CRT] device) and over time. A mixed-brand system was implanted in 4.1% (95% CI, 3.6-4.6%) of analyzed patients or, by device type, in 4.5% (3.5-5.7%) of pacemaker patients, 1.1% (0.7-1.7%) of ICD patients, and 6.8% (5.7-7.9%) of CRT pacemaker/defibrillator patients (p < 0.001). Prevalence of mixed-brand implants exhibited significant temporal fluctuations, first declining from 6.6% (2012-2014) to 1.3% (2019), and then increasing to 5.1% (2022). Temporal changes were statistically significant for pacemakers (p < 0.001) and CRT devices (p = 0.001), but not for ICDs (p = 0.438). In the decade between 2012 and 2022, mixed-brand CIED systems were more prevalent in patients treated with pacemakers and CRT devices than in ICD recipients. A decline in the prevalence of mixed-brand systems was observed after the introduction of MRI-conditional systems, reaching a minimum in 2019, followed by a progressive increase in the subsequent years., (© 2024. The Author(s).)

Cytomegalovirus (CMV) colitis is a serious concern worsening the prognosis of patients with ulcerative colitis (UC). We aimed to assess risk factors and prognostic impact of CMV colitis in patients with moderate-to-severe UC flare. We conducted a retrospective, observational, single-center study. Consecutive adult patients hospitalized for moderate-to-severe UC from January 2020 to June 2023 were included. The primary endpoint was a diagnosis of CMV-colitis according to immunohistochemistry on tissue biopsies. The secondary endpoint was the need for colectomy within 30 days. Overall, 135 patients were included. CMV colitis was diagnosed in n = 37 (27.4%): n = 19 (51.4%) endoscopically, the remaining on surgical specimens. Of them, n = 23 (62.2%) had positive CMV-DNAemia with a median value of 1,008 cp/mL (interquartile range 318-2,980). Differences between the two groups (CMV colitis vs non-CMV) included age (60 vs 41 years, P = 0.004), Charlson Comorbidity Index (1 vs 0, P = 0.003), steroid refractoriness (86.5% vs 62.2%, P = 0.007), and positive CMV-DNAemia (62.2% vs 10.1%, P < 0.001). At multivariable analysis, steroid-refractory disease, Charlson Comorbidity Index, and CMV-DNAemia were associated with CMV colitis. Overall, n = 54 (39.7%) patients underwent colectomy, and this was significantly more common in patients with CMV colitis vs non-CMV group (54.1% vs 34.4%, P = 0.049). Kaplan-Meier showed that antiviral therapy seems to have a relevant impact on colectomy ( P < 0.001). CMV-DNA blood detection is independently associated with CMV-positive refractory UC. Since CMV colitis may increase the risk of colectomy and antiviral treatment seems to reduce such risk, prospective studies are needed to confirm the role of CMV-DNA blood detection to early diagnose CMV colitis., Importance: Cytomegalovirus (CMV) colonic reactivation worsens the prognosis of patients with active ulcerative colitis. Blood CMV-DNA reactivation is strongly associated with CMV colitis. Prompt diagnosis and treatment of CMV colitis can avoid surgery in most cases., Competing Interests: P.G. received honoraria from Janssen, Abbvie, Pfizer, Celgene, Takeda, Ferring, MSD, Amgen, and Alfa-Sigma, and he participated in a company sponsored speaker's bureau of Abbvie, Janssen, Takeda, FGerring, MSD, Sofar, and Chiesi. F.R. received honoraria from Janssen, Abbvie, Pfizer, Takeda, Ferring, and MSD, and he participated in a company sponsored speaker's bureau of Abbvie, Jansen, Takeda, Ferring, MSD, Sofar, and Chiesi. The other authors have no conflicts of interest to declare.

Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Background: To clarify whether next-generation sequencing (NGS) can be useful for resistance assessment in virologically suppressed highly treatment-experienced (HTE) individuals with MDR HIV., Methods: Ninety-one participants from the PRESTIGIO Registry were included. NGS was performed on HIV-DNA at 1%, 5% and 20% cut-offs; major drug resistance mutations (DRMs) were evaluated and compared with those detected in historical plasma genotypic resistance testing (h-GRT). APOBEC editing was also characterized., Results: Participants had a complex and long treatment history [median 23 (IQR 21-25) years of ART exposure) and had been virologically suppressed since a median of 3 (IQR 2-5) years. Among all major DRMs detected by HIV-DNA NGS and/or h-GRT, 30% were exclusively found through NGS. The highest detection rate of historical major DRMs was reached with NGS set at 1%, but unusual substitutions and extensive APOBEC hypermutations suggest technical issues and poor clinical relevance in the 1%-5% interval. At NGS set at 5%, 67.2% of historical major DRMs were detected. The number of major DRMs detected exclusively by DNA-NGS as minority variants (frequency 5%-20%) was significantly higher in individuals who later experienced virological rebound compared with those who maintained virological control [median 2 (IQR 1-3) versus 1 (0-2), P = 0.030] and positively correlated with viraemia levels at rebound (rho = 0.474, P = 0.030)., Conclusions: In non-viraemic people with an MDR virus, HIV-1 DNA NGS set at 5% is an acceptable technical cut-off that might help to reveal mutations with a potential clinical relevance. Moreover, the number of minority resistance mutations additionally detected by NGS might be associated with loss of virological control., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Atrial high-rate episodes (AHREs) are frequent in patients with cardiac implantable electronic devices. A decrease in device-detected P-wave amplitude may be an indicator of periods of increased risk of AHRE., Objective: The objective of this study was to assess the association between P-wave amplitude and AHRE incidence., Methods: Remote monitoring data from 2579 patients with no history of atrial fibrillation (23% pacemakers and 77% implantable cardioverter-defibrillators, of which 40% provided cardiac resynchronization therapy) were used to calculate the mean P-wave amplitude during 1 month after implantation. The association with AHRE incidence according to 4 strata of daily burden duration (≥15 minutes, ≥6 hours, ≥24 hours, ≥7 days) was investigated by adjusting the hazard ratio with the CHA 2 DS 2 -VASc score., Results: The adjusted hazard ratio for 1-mV lower mean P-wave amplitude during the first month increased from 1.10 (95% confidence interval [CI], 1.05-1.15; P < .001) to 1.18 (CI, 1.09-1.28; P < .001) with AHRE duration strata from ≥15 minutes to ≥7 days independent of the CHA 2 DS 2 -VASc score. Of 871 patients with AHREs, those with 1-month P-wave amplitude <2.45 mV had an adjusted hazard ratio of 1.51 (CI, 1.19-1.91; P = .001) for progression of AHREs from ≥15 minutes to ≥7 days compared with those with 1-month P-wave amplitude ≥2.45 mV. Device-detected P-wave amplitudes decreased linearly during the 1 year before the first AHRE by 7.3% (CI, 5.1%-9.5%; P < .001 vs patients without AHRE)., Conclusion: Device-detected P-wave amplitudes <2.45 mV were associated with an increased risk of AHRE onset and progression to persistent forms of AHRE independent of the patient's risk profile., Competing Interests: Disclosures Mauro Biffi has held educational activity and participated in speaker’s bureau on behalf of Boston Scientific, Biotronik, and Medtronic. Matteo Ziacchi has held educational activity and participated in speaker’s bureau on behalf of Medtronic. Daniele Giacopelli and Alessio Gargaro are employees of Biotronik Italia S.p.a. The remaining authors have no major conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Sydenham's chorea (SC), an autoimmune disorder affecting the central nervous system, is a pivotal diagnostic criterion for acute rheumatic fever. Primarily prevalent in childhood, especially in developing countries, SC manifests with involuntary movements and neuropsychiatric symptoms. Predominantly occurring between ages 5 and 15, with a female bias, SC may recur, particularly during pregnancy or estrogen use. The autoimmune response affecting the basal ganglia, notably against dopamine, underlies the pathophysiology. Clinical management necessitates an integrated approach, potentially involving immunomodulatory therapies. To address discrepancies in SC management, a survey was conducted across Italy, targeting specialists in neurology, pediatrics, child neuropsychiatry, and rheumatology. Of the 51 responding physicians, consensus favored hospitalization for suspected SC, with broad support for laboratory tests and brain MRI. Treatment preferences showed agreement on oral prednisone and IVIG, while opinions varied on duration and plasmapheresis. Haloperidol emerged as the preferred symptomatic therapy. Post-SC penicillin prophylaxis and steroid therapy gained strong support, although opinions differed on duration. Follow-up recommendations included neuropsychological and cardiological assessments. Despite offering valuable insights, broader and more studies are needed in order to guide treatment decisions in this well-known yet challenging complication of acute rheumatic fever, which continues to warrant scientific attention and concerted clinical efforts., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Aim: The phase III randomized controlled trial (RCT) CARTITUDE-4 (NCT04181827) demonstrated superiority of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) over daratumumab, pomalidomide and dexamethasone (DPd) and pomalidomide, bortezomib and dexamethasone (PVd) for relapsed/refractory multiple myeloma (RRMM) patients who have received one to three prior line(s) of therapy (LOT[s]) including an immunomodulatory agent and a proteasome inhibitor, and are refractory to lenalidomide. These analyses estimate the relative efficacy between cilta-cel and other common treatment regimens, for which no direct comparative evidence is available. Materials & methods: Patient data were available from the CARTITUDE-4, CASTOR, CANDOR and APOLLO RCTs. Imbalances between cohorts on key patient characteristics were adjusted for using inverse probability of treatment weighting (IPTW). Relative efficacies were estimated with response rate ratios (RRs) and 95% confidence intervals (CIs) for overall response rate (ORR), very good partial response or better rate (≥VGPR) and complete response or better rate (≥CR), and with hazard ratios (HRs) and 95% CIs for progression-free survival (PFS). Sensitivity analyses using different analytical methods and additional covariates were explored. Results: Key characteristics were well balanced across cohorts after IPTW. Cilta-cel showed statistically significant benefit in PFS (HRs: 0.11-0.51), ≥VGPR (RRs: 1.51-5.13) and ≥CR (RRs: 2.90-35.24) versus all comparators, and statistically significant improvements in ORR over most comparator regimens (RRs: 1.22-1.90). Results were consistent across sensitivity analyses. Conclusion: Cilta-cel demonstrated benefit over other common treatment regimens, highlighting its potential to become a new standard of care option for lenalidomide-refractory RRMM patients with one to three prior LOT(s). These comparisons help to demonstrate the improved efficacy of cilta-cel in countries where the standard of care may differ from DPd/PVd.

Carotid-cavernous fistulas (CCFs) are rare intracranial vascular malformations. Among the various classifications available, the most recently proposed highlights the strong correlation between venous drainage pattern and clinical presentation. We present the case of a woman in her 70s with a history of transient palsy of the fourth cranial nerve who presented with subacute cervical myelopathy, which was caused by a CCF with venous drainage into the peribulbar and perimedullary plexus.Given this atypical presentation of CCF and the diagnostic challenges it poses, we conducted a comprehensive PubMed search looking for CCFs presenting with cervical myelopathy and our results confirmed their rarity and allowed us to identify clinical elements that may help clinicians diagnose and manage this potentially treatable condition., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Objectives: Diagnosis of tuberculous pleurisy (TP) may be challenging and it often requires pleural biopsy. A tool able to increase pre-test probability of TP may be helpful to guide diagnostic work-up and enlargement of internal mammary lymph node (IMLN) has been suggested to play a potential role. The aim of the present investigation was to assess role of IMLN involvement in TP in a multi-centric case-control study, by comparing its prevalence and test performance to those observed in patients with infectious, non-tuberculous pleurisy (NTIP), and in controls free from respiratory diseases (CP)., Methods: A total of 419 patients, from 14 Pulmonology Units across Italy were enrolled (127 patients affected by TP, 163 affected by NTIP and 129 CP). Prevalence, accuracy and predictive values of ipsilateral IMLN involvement between cases and control groups were assessed, as well as concordance between chest computed tomography (CT scan) and thoracic ultrasound (TUS) measurements., Results: The prevalence of ipsilateral IMLN involvement in TP was significantly higher than that observed in NTIP and CP groups (respectively 77.2%, 39.3% and 14.7%). Results on test performance, stratified by age, revealed a high positive predictive value in patients aged ≤50 years, while a high negative predictive value in patients aged >50 years. The comparison between CT scan and ultrasound showed moderate agreement (Kappa=0.502)., Conclusions: Evaluation of IMLN involvement plays a relevant role in assessing the pre-test probability of TP. Considering the increasing global prevalence of mycobacterial infections, a tool able to guide diagnostic work-up of suspected TP is crucial, especially where local sources are limited., Competing Interests: Conflicts of interest None., (Copyright © 2022 Sociedade Portuguesa de Pneumologia. Published by Elsevier España, S.L.U. All rights reserved.)

The reduced penetrance of TBP intermediate alleles and the recently proposed possible digenic TBP/STUB1 inheritance raised questions on the possible mechanism involved opening a debate on the existence of SCA48 as a monogenic disorder. We here report clinical and genetic results of two apparently unrelated patients carrying the same STUB1 variant(c.244G > T;p.Asp82Tyr) with normal TBP alleles and a clinical picture fully resembling SCA48, including cerebellar ataxia, dysarthria and mild cognitive impairment. This report provides supportive evidence that this specific ataxia can also occur as a monogenic disease, considering classical TBP allelic ranges., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Carotid artery stenting (CAS) in the treatment of significant stenosis is a cause of stroke due to both plaque prolapse and cerebral embolization. New types of stents with a double-layer structure have been designed to minimize plaque prolapse and embolization; these double-layer stents (DLSs) should be able to reduce the stroke risk; however, definite data on their performance are scarce in the literature., Methods: A systematic search was performed through PubMed, Scopus, and Cochrane Library, according to PRISMA guidelines; all studies on CAS with DLS (Roadsaver/Casper or CGuard) up to January 1, 2022, with a cohort of at least 20 patients were considered eligible. The present meta-analysis was approved and registered on PROSPERO register (CRD42022297512). Patients with tandem lesions or complete carotid occlusion were excluded from the study. The 30-day stroke rate after CAS was analyzed evaluating the preoperative symptomatic status and DLS occlusion. The estimated pooled rate of events was calculated by random effect model and moderators were evaluated., Results: A total of 14 studies were included in the meta-analysis for a total of 1955 patients. The estimated overall (95% confidence interval [CI]) stroke rate was 1.4% (0.9%-2.2%, I 2 = 0%), which was not influenced by the type of DLS used: CGuard 0.8% (0.4%-1.8%, I 2 = 0%) versus Roadsaver/Casper 1.5% (0.7%-3.2%, I 2 = 0%), p=0.30. The 30-day estimated stroke rate was 1.5% (0.8%-2.9%, I 2 = 0%) in asymptomatic and 1.9% (1.0%-3.6%, I 2 = 0%) in symptomatic patients, with no influence by moderators. The 30-day DLS occlusion rate was 0.8% (0.4%-1.8%, I 2 = 0%). The publication bias assessment identified asymmetry in the asymptomatic populations., Conclusion: The overall 30-day stroke rate in CAS with DLS is low (1.4%), with similar results in symptomatic and asymptomatic patients. Acute occlusion of DLS is rare (0.8%). Further studies are necessary to reduce the publication bias for asymptomatic patients., Clinical Impact: CAS with DLS is associated to a low rate of 30-day stroke in both symptomatic (1.9%) and asymptomatic (1.5%) patients. The type of DLS (CGuard or Roadsaver/Casper) did not affect the 30-day stroke rate., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. The primary analysis of the Ro-CHOP phase III randomized controlled trial (ClinicalTrials.gov identifier: NCT01796002) established that romidepsin (Ro) plus cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) did not yield an increased efficacy compared with CHOP alone as first-line treatment of peripheral T-cell lymphoma. We report the planned final analysis 5 years after the last patient enrolled. With a median follow-up of 6 years, median progression-free survival (PFS) was 12.0 months compared with 10.2 months (hazard ratio [HR], 0.79 [95% CI, 0.62 to 1.005]; P = .054), while median overall survival was 62.2 months (35.7-86.6 months) and 43.8 months (30.1-70.2 months; HR, 0.88 [95% CI, 0.68 to 1.14]; P = .324) in the Ro-CHOP and CHOP arms, respectively. In an exploratory analysis, the median PFS in the centrally reviewed follicular helper T-cell lymphoma subgroup was significantly longer in the Ro-CHOP arm (19.5 v 10.6 months, HR, 0.703 [95% CI, 0.502 to 0.985]; P = .039). Second-line treatments were given to 251 patients with a median PFS2 and OS2 after relapse or progression of 3.3 months and 11.5 months, respectively. Within the limits of highly heterogeneous second-line treatments, no specific regimen seemed to provide superior disease control. However, a potential benefit was observed with brentuximab vedotin in association with chemotherapy even after excluding anaplastic large-cell lymphoma subtype or after adjusting for histology and international prognostic index in a multivariate model (HR for PFS, 0.431 [95% CI, 0.238 to 0.779]; P = .005).

The treatment of patients with diabetic foot ulcers (DFUs) is extremely complex, requiring a comprehensive approach that involves a variety of different healthcare professionals. Several studies have shown that a multidisciplinary team (MDT) approach is useful to achieve good clinical outcomes, reducing major and minor amputation and increasing the chance of healing. Despite this, the multidisciplinary approach is not always a recognized treatment strategy. The aim of this meta-analysis was to assess the effects of an MDT approach on major adverse limb events, healing, time-to-heal, all-cause mortality, and other clinical outcomes in patients with active DFUs. The present meta-analysis was performed for the purpose of developing Italian guidelines for the treatment of diabetic foot with the support of the Italian Society of Diabetology (Società Italiana di Diabetologia, SID) and the Italian Association of Clinical Diabetologists (Associazione Medici Diabetologi, AMD). The study was performed using the Grading of Recommendations Assessment, Development, and Evaluation approach. All randomized clinical trials and observational studies, with a duration of at least 26 weeks, which compared the MDT approach with any other organizational strategy in the management of patients with DFUs were considered. Animal studies were excluded. A search of Medline and Embase databases was performed up until the May 1st, 2023. Patients managed by an MDT were reported to have better outcomes in terms of healing, minor and major amputation, and survival in comparison with those managed using other approaches. No data were found on quality of life, returning-to-walking, and emergency admission. Authors concluded that the MDT may be effective in improving outcomes in patients with DFUs., (© 2024. Springer-Verlag Italia S.r.l., part of Springer Nature.)

Background: There are no unequivocal histopathological findings for the diagnosis of fatal asphyxia due to neck compression. From the observation of a series of asphyxiation cases, we noted, during microscopic analysis, a high frequency of "detachment" of soft tissues from the hyoid bone. This specifically refers to the presence of an optical space between the surface of the hyoid bone and soft tissues., Objectives: We aimed to evaluate the detachment of soft tissues from the hyoid bone as specific histological evidence of death due to strangulation asphyxia., Material and Methods: Ten blocks were taken from deaths due to external mechanical compression of the neck (strangulation asphyxia, group A), 22 blocks were taken from deaths for other causes without trauma to the neck (group B), and 38 blocks were obtained from living subjects that have undergone laryngectomies (group C). The presence/absence of detachments were compared between the 3 groups (A, B and C) using Fisher's exact test., Results: The detachment of soft tissues from the hyoid bone was observed in 5 cases (50%) in group A, 6 cases (27.2%) in group B, and 17 cases (44.3%) in group C. The sensitivity and specificity of the presence of the detachment in group A were 0.5 (95% confidence interval (95% CI): 0.38-0.62) and 0.57 (95% CI: 0.45-0.69), respectively. The comparison between the 3 groups and the presence/absence of soft tissue detachment showed no statistically significant differences between the groups (p = 0.329), clarifying that soft tissue detachment is a nonspecific variable for all 3 situations., Conclusions: Detachment of soft tissues has poor value as a single element to favor the diagnosis of asphyxia due to violent compression of the neck and should be interpreted as an artifactual finding, unrelated to the neck injury or injury vitality.

Smaller pelvic floor dimensions seem to have been an evolutionary need to provide adequate support for the pelvic organs and the fetal head. Pelvic floor dimension and shape contributed to the complexity of human birth. Maternal pushing associated with pelvic floor muscle relaxation is key to vaginal birth. Using transperineal ultrasound, pelvic floor dimensions can be objectively measured in both static and dynamic conditions, such as pelvic floor muscle contraction and pushing. Several studies have evaluated the role of the pelvic floor in labor outcomes. Smaller levator hiatal dimensions seem to be associated with a longer duration of the second stage of labor and a higher risk of cesarean and operative deliveries. Furthermore, smaller levator hiatal dimensions are associated with a higher fetal head station at term of pregnancy, as assessed by transperineal ultrasound. With maternal pushing, most women can relax their pelvic floor, thus increasing their pelvic floor dimensions. Some women contract rather than relax their pelvic floor muscles under pushing, which is associated with a reduction in the anteroposterior diameter of the levator hiatus. This phenomenon is called levator ani muscle coactivation. Coactivation in nulliparous women at term of pregnancy before the onset of labor is associated with a higher fetal head station at term of pregnancy and a longer duration of the second stage of labor. In addition, levator ani muscle coactivation in nulliparous women undergoing induction of labor is associated with a longer duration of the active second stage of labor. Whether we can improve maternal pelvic floor relaxation with consequent improvement in labor outcomes remains a matter of debate. Maternal education, physiotherapy, and visual feedback are promising interventions. In particular, ultrasound visual feedback before the onset of labor can help women increase their levator hiatal dimensions and correct levator ani muscle coactivation in some cases. Ultrasound visual feedback in the second stage of labor was found to help women push more efficiently, thus obtaining a lower fetal head station at ultrasound and a shorter duration of the second stage of labor. The available evidence on the role of any intervention aimed to aid women to better relax their pelvic floor remains limited, and more studies are needed before considering its routine clinical application., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: In the surgical treatment of head and neck locally advanced malignancies, microvascular free flaps represent the most valuable solution to reconstruct the tissue defect after resection of the primary neoplasm. In particular, microvascular free flaps allow to restore the functional and aesthetical features of the head and neck compartments. The superficial circumflex iliac perforator (SCIP) flap represents, as an evolution of the groin flap, a valid alternative to the radial fasciocutaneous free (RFFF) flap or the anterolateral thigh (ALT) flap., Methods: This systematic review adhered to the recommendations of the Preferred Reporting Items of Systematic Reviews and Meta-analysis (PRISMA) 2009 guidelines. A computerized MEDLINE search was performed using the PubMed service of the U.S. National Library of Medicine ( www.pubmed.org ) and Scopus database ( www.scopus.com ). Two authors screened the articles, then selected and extracted data on malignancies characteristics, reconstructive techniques, outcomes, and complications., Results: A total of 25 articles were selected and reviewed among the 39 identified through the search string. Six out of the selected 25 articles were case reports, while the remaining 19 articles were retrospective case series. The whole study population was represented by 174 oncologic patients undergoing ablation of a head and neck tumor and reconstruction with a SCIP flap. The site of reconstruction was the oral cavity in 125 (71.0%) patients, being the tongue the most common subsite in 73 (41.5%) patients, the pharynx in 10 (5.7%) cases, the larynx in 3 (1.7%) and head and neck skin in 36 (20.4%) patients. Only two cases of total flap loss were reported. Partial flap loss or shrinkage requiring minor surgical revisions was observed in 11 patients (6.32%). Primary closure of the donor site was achieved in the whole study population, according to the available data., Conclusions: In head and neck postoncological reconstruction, despite the caliber and the length of the pedicle, SCIP flap offers a pliable and thin skin paddle, allowing single-stage resurfacing, medium to large skin paddle, possibility of composite-fashion harvest and a well-concealed donor site., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background and Purpose: Parapharyngeal space (PPS) neoplasms represent 1% of all head and neck tumors and are mostly benign. Surgery is the mainstay of treatment and the transcervical-transparotid (TC-TP) corridor still represents the workhorse for adequate PPS exposure. Our series investigates strengths and limits of this approach on a multi-institutional basis., Methods: We reviewed consecutive patients submitted to PPS surgery via TC-TP route between 2010 and 2020. Hospital stay, early and long-term complications, and disease status were assessed., Results: One hundred and twenty nine patients were enrolled. Most tumors were benign (79.8%) and involved the prestyloid space (83.7%); the median largest diameter was 4.0 cm. The TC-TP corridor was used in 70.5% of patients, while a pure TC route in about a quarter of cases. Early postoperative VII CN palsy was evident in 32.3% of patients, while X CN deficit in 9.4%. The long-term morbidity rate was 34.1%, with persistent CN impairment detectable in 26.4% of patients: carotid space location, lesion diameter and malignant histology were the main independent predictors of morbidity. A recurrence occurred in 12 patients (9.4%)., Conclusions: The TC-TP corridor represents the benchmark for surgical management of most of PPS neoplasms, though substantial morbidity can still be expected., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objectives: Left pulmonary artery (LPA) or bifurcation stenoses at Fontan palliation can be very challenging to treat and may also require cardioplegia and aortic transection. Moreover, the low pressure of Fontan circulation and the bulkiness of the aorta increase the risk of a patch angioplasty collapse. Pre-Fontan LPA stenting of stenotic LPAs overcomes those drawbacks therefore the present study aimed to evaluate its advantageous impact on Fontan surgery., Methods: A multicentre retrospective analysis was performed on 304 consecutive Fontan patients. The study population was divided into 2 groups (LPA stented, n = 62 vs not stented, n = 242); pre-and postoperative data were compared., Results: LPA-stented patients had a higher prevalence of systemic right ventricle (P = 0.01), hypoplastic left heart syndrome (P = 0.042), complex neonatal palliations (Norwood/Damus-Kaye-Stansel) and surgical LPA patch repair at Glenn (P < 0.001). No differences were found in cross-clamp rates, early (P = 0.29) and late survival (94.6% vs 98.4, P = 0.2) or complications (P = 0.14). Complex palliations on ascending aorta/aortic arch (P = 0.013) and surgical LPA repair at Glenn (P < 0.001) proved to be risk factors for LPA stenting before Fontan at multivariable analysis., Conclusions: The LPA-stented group showed similar outcomes in terms of survival and complications rate compared to patients without LPA stenosis; however, they significantly differ in their higher preoperative risk profile and in their more complex anatomy. Complex neonatal palliations involving ascending aorta or aortic arch may increase the risk of pulmonary branches stenosis requiring stenting; therefore, preoperative stenting of LPA stenoses could help to reduce the surgical risk of complex Fontan procedure by avoiding the need for cross-clamp or complex mediastinal dissections to perform a high-risk surgical repair., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Definitive data on the long-term success of the latest antiretroviral therapy (ART) strategies are still lacking. A panel of infectious diseases specialists was convened to develop a consensus on how to tailor and follow ART over time. Panelists used a Delphi technique to develop a list of statements describing preferred management approaches for ART and patient monitoring and quality of life evaluation. Ninety infectious diseases specialists from several Infectious Diseases Centers in Italy participated in the consensus process. A consensus was reached on virological and immunological parameters to use to monitor long-term efficacy of antiretroviral treatment, while there was no consensus on the use of specific inflammation and immune-activation markers in clinical routine. The panel agreed on the need for an antiretroviral treatment with the lowest impact on bone, kidney and cardiovascular toxicity and on the utility of quality-of-life monitoring during the standard follow up of people living with HIV. The consensus statements developed by a panel of infectious diseases specialists may provide guidance to practitioners for a person-centered approach aimed at obtaining long-term virological and clinical success for people living with HIV.

Introduction: The evaluation of upcoming Aortic Coarctation (CoA) in new-borns with prenatal suspicion entails a close echocardiographic monitor until Arterial Duct (AD) closure, in a department with pediatric cardiological and surgical expertise. The significant number of false-positive prenatal diagnoses causes parental stress and healthcare costs., Aim: The aim of this study was to elaborate an echocardiographic prediction model to be employed at birth when PDA is still present, in patients suspected of CoA during fetal life in order to foretell CoA requiring neonatal surgical intervention., Methods: This retrospective monocentric study included consecutive full-term and late preterm neonates with prenatal suspicion of CoA born from 01 January 2007 to 31 December 2020. Patients were divided into two groups according to the need for aortic surgery (CoA - NoCoA). All patients underwent a comprehensive transthoracic echocardiographic exam in presence of PDA. Multivariable logistic regression was used to create a coarctation probability model (CoMOD) including isthmal (D4), transverse arch (D3) diameters, the distance between a left common carotid artery (LCA) and left subclavian artery (LSA), presence/absence of ventricular septal defect (VSD) and bicuspid aortic valve (BAV)., Results: We enrolled 87 neonates (49 male, 56%). 44 patients developed CoA in need of surgical repair. Our index CoMOD showed an AUC = 0.9382, high sensitivity (91%) and specificity (86%) in the prediction of CoA in neonates with prenatal suspicion. We classified neonates with CoMOD > 0 to be at high risk for surgical correction of CoA, with good PPV (86.9%) and NPV (90.9%)., Conclusions: CoMOD > 0 is highly suggestive of the need for CoA corrective surgery in newborns with prenatal suspicion.

Objective: This post-market multicenter registry aimed to evaluate the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. In this subgroup analysis, we assessed the outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair at 1 year., Methods: A single cohort from a prospective, multicenter, observational, 16-site European registry. Patients were enrolled from November 2018 to March 2022. Endpoints included 1-year primary patency (PP), primary assisted patency (PAP), and secondary patency (SP), stent graft-related death and serious adverse events through 30 days., Results: Seventy-three patients were enrolled in this registry sub-cohort, 57 (78.1%) were male, and the mean age was 73 ± 8.1 years. Thoracoabdominal aneurysms predominated the cohort with 68 patients (93.2%), followed by five patients (6.8%) with pararenal and infrarenal aneurysms. Overall, 233 target vessels were treated with the index bridging graft. The overall per stent graft analysis demonstrated a PP of 95.8% at 1 year; PAP was 95.8%, and SP reached 97.9%. The per-target vessel analysis demonstrated a PP, PAP, and SP in the celiac trunk of 100%, 100%, and 100%; in the superior mesenteric artery of 96.0%, 96.0%, and 100%, and in the renal arteries of 94.2%, 94.2%, and 95.1%, respectively. Four patients (5%) died at 1 year; none of the deaths were device-related. The composite endpoint of target vessel technical success and freedom from VBX stent-related serious adverse events through 30 days was achieved in 98.6% of patients., Conclusions: In this prospective post-market multicenter registry, the VBX stent demonstrated excellent results at 1 year, with almost 96% primary patency and 98% secondary patency. Patency in the renal arteries seems to be lower. Nevertheless, the VBX stent appears to be a reliable bridging stent for branched endovascular aortic repair., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Aims: Diabetic foot syndrome (DFS) and its complications are a growing public health concern. The Italian Society of Diabetology (SID) and the Italian Association of Clinical Diabetologists (AMD), in collaboration with other scientific societies, will develop the first Italian guidelines for the treatment of DFS., Methods: The creation of SID/AMD Guidelines is based on an extended work made by 19 panelists and 12 members of the Evidence Review Team. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology has been used to decide aims, reference population, and target health professionals. Clinical questions have been created using PICO (Patient, Intervention, Comparison, Outcome) conceptual framework. The definition of questions has been performed using a two-step web-based Delphi methodology, a structured technique aimed at obtaining by repeated rounds of questionnaires a consensus opinion from a panel of experts in areas wherein evidence is scarce or conflicting, and opinion is important., Results: The mean age of panelists (26.3% women) was 53.7 ± 10.6 years. The panel proposed 34 questions. A consensus was immediately reached for all the proposed questions, 32 were approved and 2 were rejected., Conclusions: The areas covered by clinical questions included diagnosis of ischemia and infection, treatment of ischemic, neuropathic, and infected ulcers, prevention of foot ulceration, organization and education issues, and surgical management. The PICO presented in this paper are designed to provide indications for healthcare professionals in charge of diabetic foot treatment and prevention, primarily based on clinical needs of people with diabetic foot syndrome and considering the existing organization of health care., (© 2023. Springer-Verlag Italia S.r.l., part of Springer Nature.)

Background: The identification of a "low-voltage bridge" to guide ablation of atrioventricular nodal reentry tachycardia (AVNRT) has been described as a safe and effective strategy in children. We investigated the presence of a low-voltage bridge in adult patients undergoing AVNRT ablation, to evaluate its anatomical correspondence with the successful ablation site. We also investigated the possible correlations between Koch's triangle anatomy and patients' biometric characteristics., Methods: This observational registry prospectively collected data from 200 patients undergoing AVNRT ablation, guided by 3D electroanatomical mapping system, in 6 electrophysiology centers. Koch's triangle voltage map was collected; then, the anatomical correspondence between the low-voltage bridge and the successful ablation site was evaluated. Koch's triangle anatomical dimensions were subsequently drawn from the mapping system and correlated to patients' gender, age, and weight., Results: The low-voltage bridge was identified in 159 over 200 procedures (79.5%). When the low-voltage bridge was identified, its anatomical correspondence with the successful ablation site has been proved in 137 over 159 cases (86%), with a reduction of radiofrequency deployment time. No strict correlations were found, on the other side, between Koch's triangle anatomy and patients' biometric data., Conclusions: The identification of the low-voltage bridge has proved to be a helpful strategy to guide AVNRT ablation in a large cohort of adult patients. Targeting the low-voltage bridge during AVNRT ablation helps to reduce RF application time. Koch's triangle morphological characteristics cannot be predicted on the base of patients' biometric data., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

In the present study, we aimed to evaluate the absolute risk of infection in the real-life setting of AML patients treated with CPX-351. The study included all patients with AML from 30 Italian hematology centers of the SEIFEM group who received CPX-351 from July 2018 to June 2021. There were 200 patients included. Overall, 336 CPX-351 courses were counted: all 200 patients received the first induction cycle, 18 patients (5%) received a second CPX-351 induction, while 86 patients (26%) proceeded with the first CPX-351 consolidation cycle, and 32 patients (10%) received a second CPX-351 consolidation. A total of 249 febrile events were recorded: 193 during the first or second induction, and 56 after the first or second consolidation. After the diagnostic work-up, 92 events (37%) were classified as febrile neutropenia of unknown origin (FUO), 118 (47%) were classifiable as microbiologically documented infections, and 39 (17%) were classifiable as clinically documented infections. The overall 30-day mortality rate was 14% (28/200). The attributable mortality-infection rate was 6% (15/249). A lack of response to the CPX-351 treatment was the only factor significantly associated with mortality in the multivariate analysis [ p -value: 0.004, OR 0.05, 95% CI 0.01-0.39]. Our study confirms the good safety profile of CPX-351 in a real-life setting, with an incidence of infectious complications comparable to that of the pivotal studies; despite prolonged neutropenia, the incidence of fungal infections was low, as was infection-related mortality.

Italian Research Group for Gastric Cancer (GIRCG), during the 2013 annual Consensus Conference to gastric cancer, stated that laparoscopic or robotic approach should be limited only to early gastric cancer (EGC) and no further guidelines were currently available. However, accumulated evidences, mainly from eastern experiences, have supported the application of minimally invasive surgery also for locally advanced gastric cancer (AGC). The aim of our study is to give a snapshot of current surgical propensity of expert Italian upper gastrointestinal surgeons in performing minimally invasive techniques for the treatment of gastric cancer in order to answer to the question if clinical practice overcome the recommendation. Experts in the field among the Italian Research Group for Gastric Cancer (GIRCG) were invited to join a web 30-item survey through a formal e-mail from January 1st, 2020, to June 31st, 2020. Responses were collected from 46 participants out of 100 upper gastrointestinal surgeons. Percentage of surgeons choosing a minimally invasive approach to treat early and advanced gastric cancer was similar. Additionally analyzing data from the centers involved, we obtained that the percentage of minimally invasive total and partial gastrectomies in advanced cases augmented with the increase of surgical procedures performed per year (p = 0.02 and p = 0.04 respectively). It is reasonable to assume that there is a widening of indications given by the current national guideline into clinical practice. Propensity of expert Italian upper gastrointestinal surgeons was to perform minimally invasive surgery not only for early but also for advanced gastric cancer. Of interest volume activity correlated with the propensity of surgeons to select a minimally invasive approach., (© 2022. Italian Society of Surgery (SIC).)

Background: Critical limb threatening-ischemia (CLTI) can be due to an extensive involvement of both the aorto-iliac (AI) and the infra-inguinal (II) districts and the efficacy of and extensive AI+II vs. only AI revascularization is still matter of debate. The aim of the present study was to evaluate the outcome in CLTI patients with concomitant AI and II peripheral artery disease (PAD) after revascularization limited to the AI or extended also to the II segment., Methods: Patients with CLTI and concomitant AI (TransAtlantic InterSociety Consensus: C-D) and II PAD (Global-Anatomic-Staging-System: II-III) from 2016 to 2021 were retrospectively evaluated. Patients were compared according to type of revascularization: limited to AI vs. AI+II. Common femoral and profunda artery endarterectomy (C/P-TEA) was considered in both groups. Perioperative mortality, limb salvage, foot healing (within 6 months after surgery), necessity of adjunctive revascularization and survival were analyzed and the follow-up performed with clinical and duplex assessment every six months. The primary endpoint was to evaluate the composite event of limb salvage, wound healing and necessity of adjunctive revascularization during follow-up in AI vs. AI+II groups, through Kaplan Meier and Cox regression analysis., Results: Over a total of 1105 peripheral revascularizations for CLTI, 96 (8.7%) patients met the inclusion criteria for the study. AI revascularization was performed in 38 (40%) and AI+II in 58 (60%). AI and AI+II groups were similar for preoperative risk factors and extension of PAD with the exception of American Society of Anesthesiology (ASA) Classification (ASA IV: 50% vs. 25%, P=0.02, respectively). The AI group was treated with angioplasty/stenting in all cases and with C/P-TEA in 20 (52%) cases. In the AI+II group, the AI district was treated by angioplasty/stenting in 55 (95%) and by aorto-bifemoral bypass in 3 (5%) and C/P-TEA in 20 (34%). The II revascularization was performed by femoro-popliteal/tibial bypass in 27 (47%); and endovascular revascularization in 31 (53%) patients. Minor amputation rate was similar between AI and AI+II revascularization (39% vs. 48%, P=1.0); length of stay, blood transfusion units, were significantly higher in AI+II group: 7±4 days vs. 12±5 days, P=0.04 and 2±2 vs. 4±2, P=0.02. The 30-day mortality was 7% with no differences according to the type of treatment. At a mean follow-up of 28±10 months, the overall limb salvage was 87±4% with similar results in AI vs. AI+II revascularization (95±5% vs. 86±6%; P=0.56). AI had a higher necessity of adjunctive revascularization and lower wound healing compared to AI+II (18±9% vs. 0%, P=0.02; 72% vs. 100%, P=0.001, respectively). AI+II was associated with a better primary endpoint compared to AI (87±5% vs. 53±9%, P=0.01), and it was confirmed in Rutherford 5 and 6 patients (100% vs. 54±14%, P=0.01; 78±9 vs. 50±13%, P=0.04), and no differences in Rutherford 4 (100% vs. 100%). Cox regression analysis confirmed AI+II as an independent protector for the primary outcome (hazard ratio: 0.23, 95% confidence interval 0.08-0.71)., Conclusions: CLTI with extensive PAD disease can be treated with limited AI revascularization in Rutherford 4 patients however in case of category 5 or 6 an extensive revascularization (AI+II) should be considered.

Introduction: Thoracic impedance (TI) drops measured by implantable cardioverter-defibrillators (ICDs) have been reported to correlate with ventricular tachycardia/fibrillation (VT/VF). The aim of our study was to assess the temporal association of decreasing TI trends with VT/VF episodes through a longitudinal analysis of daily remote monitoring data from ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds)., Methods and Results: Retrospective data from 2384 patients were randomized 1:1 into a derivation or validation cohort. The TI decrease rate was defined as the percentage of rolling weeks with a continuously decreasing TI trend. The derivation cohort was used to determine a TI decrease rate threshold for a ≥99% specificity of arrhythmia prediction. The associated risk of VT/VF episodes was estimated in the validation cohort by dividing the available follow-up into 60-day assessment intervals. Analyses were performed separately for 1354 ICD and 1030 CRT-D patients. During a median follow-up of 2.0 years, 727 patients (30.4%) experienced 3298 confirmed VT/VF episodes. In the ICD group, a TI decrease rate of >60% was associated with a higher risk of VT/VF episode in a 60-day assessment interval (stratified hazard ratio, 1.42; 95% confidence interval (CI), 1.05-1.92; p = .023). The TI decrease preceded (40.8%) or followed (59.2%) the VT/VF episodes. In the CRT-D group, no association between TI decrease and VT/VF episodes was observed (p = .84)., Conclusion: In our longitudinal analysis, TI decrease was associated with VT/VF episodes only in ICD patients. Preventive interventions may be difficult since episodes can occur before or after TI decrease., (© 2023 Wiley Periodicals LLC.)

The aim of this study was to assess the impact of BMI on perioperative outcomes in patients undergoing VATS lobectomy or segmentectomy. Data from 5088 patients undergoing VATS lobectomy or segmentectomy, included in the VATS Group Italian Registry, were collected. BMI (kg/m 2 ) was categorized according to the WHO classes: underweight, normal, overweight, obese. The effects of BMI on outcomes (complications, 30-days mortality, DFS and OS) were evaluated with a linear regression model, and with a logistic regression model for binary endpoints. In overweight and obese patients, operative time increased with BMI value. Operating room time increased by 5.54 minutes (S.E. = 1.57) in overweight patients, and 33.12 minutes (S.E. = 10.26) in obese patients (P < 0.001). Compared to the other BMI classes, overweight patients were at the lowest risk of pulmonary, acute cardiac, surgical, major, and overall postoperative complications. In the overweight range, a BMI increase from 25 to 29.9 did not significantly affect the length of stay, nor the risk of any complications, except for renal complications (OR: 1.55; 95% CI: 1.07-2.24; P = 0.03), and it reduced the risk of prolonged air leak (OR: 0.8; 95% CI: 0.71-0.90; P < 0.001). 30-days mortality is higher in the underweight group compared to the others. We did not find any significant difference in DFS and OS. According to our results, obesity increases operating room time for VATS major lung resection. Overweight patients are at the lowest risk of pulmonary, acute cardiac, surgical, major, and overall postoperative complications following VATS resections. The risk of most postoperative complications progressively increases as the BMI deviates from the point at the lowest risk, towards both extremes of BMI values. Thirty days mortality is higher in the underweight group, with no differences in DFS and OS., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Aims: The safety and efficacy of leadless intracardiac-permanent pacemaker (L-PM) have been demonstrated in multiple clinical trials, but data on comparisons with conventional transvenous-permanent pacemaker (T-PM) collected in a consecutive, prospective fashion are limited. The aim of this analysis was to compare the rate and the nature of device-related complications between patients undergoing L-PM vs. T-PM implantation., Methods and Results: Prospective, multicentre, observational project enrolling consecutive patients who underwent L-PM or T-PM implantation. The rate and nature of device-related complications were analysed and compared between the two groups. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 2669 (n = 665 L-PM) patients were included and followed for a median of 39 months, L-PM patients were on average older and had more co-morbidities. The risk of device-related complications at 12 months was significantly lower in the L-PM group (0.5% vs. 1.9%, P = 0.009). Propensity matching yielded 442 matched pairs. In the matched cohort, L-PM patients trended toward having a lower risk of overall device-related complications (P = 0.129), had a similar risk of early complications (≤30 days) (P = 1.000), and had a significantly lower risk of late complications (>30 days) (P = 0.031). All complications observed in L-PM group were early. Most (75.0%) of complications observed in T-PM group were lead- or pocket-related., Conclusion: In this analysis, the risk of device-related complications associated with L-PM implantation tended to be lower than that of T-PM. Specifically, the risk of early complications was similar in two types of PMs, while the risk of late complications was significantly lower for L-PM than T-PM., Competing Interests: Conflict of interest: P.P. reports no conflicts with regard to the content of the present work, outside this work small speaker fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Novartis; M.Z. reports no conflicts with regard to the content of the present work, outside this work small speaker fees from Abbott, Boston Scientific, and Biotronik. No other conflicts of interest were reported., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Elevated resting heart rate is a risk factor for cardiovascular events., Objective: The purpose of this study was to investigate the clinical significance of nocturnal heart rate (nHR) and 24-hour mean heart rate (24h-HR) obtained by continuous remote monitoring (RM) of implantable devices., Methods: We analyzed daily-sampled trends of nHR, 24h-HR, and physical activity in patients on β-blocker therapy for chronic heart failure and with implantable cardioverter-defibrillators or cardiac resynchronization therapy defibrillators (CRT-Ds). Patients were grouped by average nHR and 24h-HR quartile during follow-up to estimate the respective incidence of nonarrhythmic death and device-treated ventricular tachycardia/fibrillation (VT/VF)., Results: The study cohort included 1330 patients (median age 69 years [interquartile range 61-77 years]; 41% [n = 550] with CRT-D; median follow-up 25 months [interquartile range 13-42 months]). Compared with patients in the lowest nHR quartile (≤57 beats/min) group, patients in the highest quartile group (>65 beats/min) had an increased risk of nonarrhythmic death (adjusted hazard ratio [AHR] 2.25; 95% confidence interval [CI] 1.13-4.50; P = .021) and VT/VF (AHR 1.98; 95% CI 1.40-2.79; P < .001) and were characterized by the lowest level of physical activity (P ≤ .0004 vs every other nHR quartiles). The highest 24h-HR quartile group (>75 beats/min) showed an increased risk of VT/VF (AHR 2.13; 95% CI 1.52-2.99; P < .001) and a weaker though significant association with nonarrhythmic mortality (AHR 1.80; 95% CI 1.00-3.22; P = .05) as compared with the lowest 24h-HR quartile group (≤65 beats/min)., Conclusion: In remotely monitored patients with implantable cardioverter-defibrillator/CRT-D on β-blocker therapy for heart failure, elevated heart rates (nHR >65 beats/min and 24h-HR >75 beats/min) were associated with increased mortality and VT/VF risk. nHR showed a stronger association than 24h-HR with worst prognosis and lowest physical activity., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aim:  Lung ultrasound (LUS) is a reliable, radiation-free, and bedside imaging technique used to assess several pulmonary diseases. Although COVID-19 is diagnosed with a nasopharyngeal swab, detection of pulmonary involvement is crucial for safe patient discharge. Computed tomography (CT) is currently the gold standard. To treat paucisymptomatic patients, we have implemented a "fast track" pathway in our emergency department, using LUS as a valid alternative. Minimal data is available in the literature about interobserver reliability and the level of expertise needed to perform a reliable examination. Our aim was to assess these., Materials and Methods:  This was a single-center prospective study. We enrolled 96 patients. 12 lung areas were explored in each patient with a semiquantitative assessment of pulmonary aeration loss in order to obtain the LUS score. Scans were performed by two different operators, an expert and a novice, who were blinded to their colleague's results., Results:  96 patients were enrolled. The intraclass correlation coefficient (ICC) showed excellent agreement between the expert and the novice operator (ICC 0.975; 0.962-0.983); demographic features (age, sex, and chronic pulmonary disease) did not influence the reproducibility of the method. The ICC was 0.973 (0.950-0.986) in males, 0.976 (0.959-0.986) in females; 0.965 (0.940-0.980) in younger patients (≤ 46 yrs), and 0.973 (0.952-0.985) in older (> 46 yrs) patients. The ICC was 0.967 (0.882-0.991) in patients with pulmonary disease and 0.975 (0.962-0.984) in the other patients. The learning curve showed an increase in interobserver agreement., Conclusion:  Our results confirm the feasibility and reproducibility of the method among operators with different levels of expertise, with a rapid learning curve., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)